EUCTR2019-002021-29-ES进行中（未招募）1 期
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Filgotinib in Subjects with Active Psoriatic Arthritis Who Have an Inadequate Response or are Intolerant to Biologic DMARD Therapy
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 390
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subjects must meet all of the following inclusion criteria to be eligible for participation in this
- •Male or female subjects who are 18-75 years of age (20-75 years of age at sites in Japan), on the day of signing initial informed consent
- •Meet Classification Criteria for Psoriatic Arthritis (CASPAR) and have a history consistent with PsA =6 months at Screening
- •Have active PsA defined as =3 swollen joints (from a 66 swollen joint count [SJC]) and =3 tender joints (from a 68 tender joint count [TJC]) at Screening and Day 1;these may or may not be the same joints at Screening and Day 1
- •Must have a documented history or active signs of at least one of the following at Screening:
- •Plaque psoriasis or nail changes attributed to psoriasis
- •Have had inadequate response or intolerance to at least one and not more than 3 bioDMARDs administered for the treatment of PsA, as per local guidelines / standard of care
- •Prior to the first dose of study drug on day 1, treatment with bioDMARDs should have been discontinued as outlined in Section 4.2 of the Protocol
- •If continuing csDMARD(s) during the study, subjects are permitted to use only a maximum of 2 of the drugs as outlined in Section 4.2 of the Protocol and must have been on this treatment for =12 consecutive weeks prior to Screening, with a stable dose and route of administration (defined as no change in prescription) for =4 weeks prior to Day 1
- •Concomitant NSAIDs or corticosteroids are permitted as specified in Sections 4.2 and 4.3 of the Protocol
- •Meet one of the TB screening criteria as described in Section 4.2 of the Protocol.
- •Able and willing to sign the informed consent as approved by the IRB/IEC
- •Subjects receiving non-prohibited medication for any reason should be on a stable dose prior to the first administration of the study drug on day 1
- •A negative serum pregnancy test result at the Screening Visit and negative urine pregnancy test result at the Day 1 Visit are required for female subjects of child bearing potential
- •Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
- •Lactating females must agree to discontinue nursing before the study drug is administered
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 280
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 110
排除标准
- •Subjects who meet any of the following exclusion criteria are not to be enrolled in this study.
- •Known hypersensitivity to the study drug, the metabolites or the formulation excipients
- •Prior PsA or psoriasis treatment with =4 bioDMARDs
- •Prior exposure to a JAK inhibitor >2 doses
- •Any active / recent infection, as specified in Section 4.3 of the Protocol
- •Any chronic and / or uncontrolled medical condition that would put the subject at increased risk during study participation or circumstances which may make a subject unlikely or unable to complete or comply with study procedures and requirements, per investigator judgement
- •Any moderately to severely active musculoskeletal or skin disorder other than PsA or plaque psoriasis that would interfere with assessment of study parameters, as per judgement of the investigator NOTE: Prior history of reactive arthritis or axial spondyloarthritis is permitted if there is documentation of change in diagnosis to PsA or additional diagnosis of PsA
- •Any history of an inflammatory arthropathy with onset before age 16 years old
- •Active autoimmune disease other than those listed above, that would interfere with assessment of study parameters or increase risk to the subject by participating in the study (e.g. uveitis, inflammatory bowel disease, uncontrolled thyroiditis, systemic vasculitis, transverse myelitis), per judgement of investigator
- •Presence of any extra-articular manifestations typically associated with rheumatoid arthritis (RA), such as rheumatoid nodules, rheumatoid lung, or other signs / symptoms, as per judgement of investigator
- •Pregnancy or nursing females
- •Active drug or alcohol abuse, as per judgement of investigator
- •Unwilling or unable to follow protocol requirements
研究者
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